In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Diabeta Drug Master File in Korea (Diabeta KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Diabeta. The MFDS reviews the Diabeta KDMF as part of the drug registration process and uses the information provided in the Diabeta KDMF to evaluate the safety and efficacy of the drug.
After submitting a Diabeta KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Diabeta API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Diabeta suppliers with KDMF on PharmaCompass.